JP4240819B2 - Atrial arrhythmia treatment device - Google Patents
Atrial arrhythmia treatment device Download PDFInfo
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- JP4240819B2 JP4240819B2 JP2000594396A JP2000594396A JP4240819B2 JP 4240819 B2 JP4240819 B2 JP 4240819B2 JP 2000594396 A JP2000594396 A JP 2000594396A JP 2000594396 A JP2000594396 A JP 2000594396A JP 4240819 B2 JP4240819 B2 JP 4240819B2
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- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- A61M25/10—Balloon catheters
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- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
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- A61B2018/00053—Mechanical features of the instrument of device
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- A61B2018/00345—Vascular system
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- A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
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- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
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- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
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- A61M25/10—Balloon catheters
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- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
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Abstract
Description
【0001】
【発明の背景】
本発明は、心房性不整脈の治療に有用な医療器具および方法に関する。特に、本発明は人体の血管、即ち、肺静脈におけるアブレーション処置に使用する好ましい方法および医療器具に関する。
【0002】
導入器とカテーテルは医療処置に長年使用されてきた。例えば、カテーテルを用いた1つの処置は、電気刺激を人体内部の特定部位に伝達することである。カテーテルを用いた別の処置は、診断試験のために体内の各種部位での活動 (度) を監視することである。即ち、カテーテルは、それ以外の方法ではより侵襲性の高い処置を行わなければ接近不可能な体内の特定部位に位置させておき、その間に検査、診断および治療を行うことができる。使用に際して、カテーテルを体表面に近い主要な静脈または動脈中に挿入すればよい。その後、カテーテルを体内の動脈または静脈を通して操作することにより、検査、診断または治療のための特定部位に誘導する。このカテーテル操作は、しばしば導入器またはガイドワイヤーといった他の医療器具の助けを借りて行われる。
【0003】
特殊なカテーテルを利用する1つの一般的な医療処置は、人体の内部に配置した血管、多くは人の心臓に付随する血管の治療である。このような処置、最も顕著な例は血管形成処置、はカテーテルを利用し、このカテーテルには膨張可能な(膨らませることのできる)バルーンが取り付けられていることが多い。この種の医療処置の一部では、カテーテルが一対の(2個の)膨張可能なバルーンを備えており、これらのバルーンは、治療される血管の部分を制限する、またはカテーテルが医療処置中ずっと血管内部の一定位置にとどまるのを確実にする、または医療処置の遂行を助ける、という目的で使用される。
【0004】
複数バルーンカテーテルは、体内のいたるところで利用されている。例えば、米国特許第5,468,239 号は、尿道管の円周方向レーザー焼灼用の器具を開示している。この器具は一対のカフまたはバルーン(60)を利用し、これらのバルーンの間に配置されたレーザープローブ(12)を備えている。米国特許第5,588,961 号は、血管への投薬供給用の注入カテーテルを開示しており、このカテーテルはこれに取り付けられた一対のバルーン(16, 17)と電極(35)とを備えている。このカテーテルには、血管内部で2つのバルーン間の空間に医薬を導入するための口が設けられている。カテーテルから離れて血管壁に向かう医薬の動きを促進するためにエネルギーを電極に導入してもよい。米国特許第5,256,141 号は、カテーテルに取り付けられた電極と共に一対のバルーン(14, 18)を開示している。この電極は2つのバルーンの間の血管内の空間に導入された材料に制御された電荷を印加するためのものである。
【0005】
生物学的材料を血管の医学的治療のためにこの空間に導入してもよい。米国特許第5,366,490 号は、カテーテルに取り付けられた一対のバルーン(30, 32)とスタイレット(36)とを開示している。高周波エネルギーが組織を破壊するためにカテーテルに供給される。米国特許第5,599,307 号は、血管を閉塞するように設計されたカテーテルに取り付けられた一対のバルーン(41, 42)を開示している。米国特許第5,002,532 号は、血管内部での拡張処置に使用するためのカテーテル(12)に取り付けられた一対のバルーン(21, 22)を開示しており、2つのバルーンは異なるレベルに膨らませてもよい。米国特許第5,792,105 号は内側バルーンと外側バルーンを利用した、流体を送給するための多流路バルーンカテーテルを開示している。米国特許第4,445,892 号も参照。
【0006】
医療処置用の単一のカテーテルに設けた複数のバルーンの使用に加えて、米国特許第5,462,529 号は、一対のカテーテル(12, 28)を備えた医療器具を開示しており、各カテーテルは、その先端(遠方端部)もしくはその付近に取り付けられた1個のバルーン(20, 48)を備え、この器具は血管内部での医療処置を行うために利用される。米国特許第5,484,412 号も、血管内部で医療処置を行うのに利用される、それぞれ膨張可能なバルーン(36, 38)を備えた、一対のカテーテル(18, 22)を開示している。米国特許第4,911,163 号は、一対のカテーテル(1, 7)に取り付けられた一対のバルーン(2, 8)を開示しており、これは2つのバルーン間の空間に医薬または診断用流体を導入するためのものである。
【0007】
心房細動は最も一般的な持続型不整脈である。これは成人人口のほぼ0.4 %以上、60歳以上の人口では恐らく10%程度も起きていると推測される。Cox, J.L. et al., 電気生理学、ペーシングおよび不整脈 (Electrophysiology, Pacing and Arrhythmia), 「心房細動の手術(Operations for Atrial Fibrillation)」, Clin. Cardiol., 14, 827-834 (1991)を参照。
【0008】
心房性不整脈は、一過性と永続性のいずれもある。多くの心房性不整脈は、根底にある別の形態の心臓病を持つ者に起こるが、一部の心房性不整脈は独立して起こる。心房性不整脈は、心室性不整脈ほどには直接死に結びつくことは少ないが、他の多くの疾患、例えば、全身および大脳の塞栓症、の危険因子を高め、多くのさらなる医療上の問題を引き起こすことがある。
【0009】
心房性不整脈の治療では、抗不整脈薬で時に軽減が得られることがある。心房性不整脈または細動の別の治療法は、体内に埋め込んだ除細動器またはカルジオバージョンを使用するものである。例えば、米国特許第5,282,836 号, 第5,271,392 号及び第5,209,229 号、並びにMartin D., et al.,心房細動 (Atrial Fibrillation), pp. 42-59 (1994)を参照。
【0010】
しかし、症候性の、または生命の危険がある、心房性不整脈の患者の中には、薬剤や上記種類の医療器具では十分に治療できない者がいる。その場合には他の形態の攻撃的な治療が必要となり、この治療は、過去には外科手術を含むことが多かった。例えば「メイズ(Maze)」法と呼ばれる心房性不整脈の治療のための外科的処置が、Cox, J.L. et al., Electrophysiology, Pacing and Arrhythmia, 心房細動の手術, Clin. Cardiol., Vol.14, pp.827-834 (1991) に開示されている。
【0011】
ある種の心臓不整脈の治療に対してここ10〜15年以内に使用が増大してきた別の処置法は、心臓組織のアブレーションを含む。例えば、この処置法は、心臓内部の不整脈に付随する既存の伝導経路を中断するか又は変形させるのに一般に使用されてきた。アブレーションのための具体的な部位は、根底にある不整脈の種類により異なる。発作性心房細動の治療に高周波カテーテルアブレーションを使用することは、Haissaguerre, M. et al.,「発作性心房細動の右および左心房高周波カテーテル療法 (Right and Left Atrial Radiofrequency Catheter Therapy of Paroxysmal Atrial Fibrillation)」J. Cardiovascular Electrophysiology, V.7, pp. 1132-1144 (1996 年12月) に開示されている。アブレーション処置は房室(AV)結節再入性頻拍の治療にも使用されている。この症状では、速いか又は遅いAV結節経路をアブレーションすることが、許容される治療法になってきた。Singer, I., et al., 「不整脈のカテーテルアブレーション (Catheter Ablation for Arrhythmias)」電気生理学の臨床マニュアル (Clinical Manual of Electorophysiology) pp. 421-431 (1993); Falk, R.H., et al.,心房細動管理メカニズム (Atrial Fibrillation Mechanisms in Management), pp.359-374 (1992); Horowitz, L.N., 最新不整脈管理 (Current Management of Arrhythmias), pp.373-378 (1991);およびMartin, D., et al., 心房細動 (Atrial Fibrillation), pp. 42-59 (1994)を参照。また、心臓内部の位置をアブレーションするためのアブレーションカテーテルの使用は、例えば、米国特許第4,641,649 号、第5,263,493 号、第5,231,995 号、第5,228,442 号および第5,281,217 号にも開示されている。
【0012】
カテーテルアブレーションに使用されるエネルギー供給源は多様である。初期には、高圧の直流電流 (DC) アブレーション法が一般に採用された。しかし、直流電流の使用に伴う諸問題のために、高周波 (Rf) エネルギーがアブレーション処置用の好ましいエネルギー供給源となってきた。高周波エネルギーを用いたアブレーションは、例えば米国特許第4,945,912 号、第5,209,229 号、第5,281,218 号、第5,242,441 号、第5,246,438 号、第5,281,213 号および第5,293,868 号に開示されている。心臓組織のアブレーションのために現に使用されているか、または使用が考えられている他のエネルギー供給源としては、レーザー、超音波、マイクロ波およびフルグトロナイゼーション(fulgutronization)] が挙げられる。
【0013】
心臓内部の正確な位置をアブレーションするには、アブレーションカテーテルを心臓の内部で正確に配置する必要がある。アブレーションカテーテルの正確な位置決めは、心臓の生理的機能からみて、特にアブレーション処置を一般に心臓が拍動している間に行うことから、特に困難である。一般に、カテーテルの配置は、電気生理学的誘導とX線 (蛍光) 透視法とを組合わせて決定される (冠状静脈洞、高右心房(high right atrium) および右心室といった既知の解剖学的構造の内部または表面に配置された放射線不透過性の診断用カテーテルによりマークされた心臓の既知の特徴的部位に対するカテーテルの配置) 。
【0014】
形状を付与した誘導導入器(guiding introducer)により特定の位置に誘導されたアブレーションカテーテルを用いた心房性不整脈のマッピングおよび治療方法が、米国特許第5,427,119 号、第5,497,774 号、第5,575,766 号、第5,564,440 号、第5,628,316 号および第5,640,955 号に開示されている。特に、心房細動の治療の1要素として、左心房および/または右心房の内部での決まったトラック (軌跡) のアブレーション法が、米国特許第5,575,766 号に開示されている。
【0015】
心房期外 (早期) 収縮のようなある種の形態の心房性不整脈の開始メカニズムは十分にはわかっていない。その結果、心臓内のアブレーション処置は、心房期外収縮に付随する電気信号の通過を阻止するか、または心房性不整脈を生ずることのある心臓内部の不適切な電気経路の形成を阻止するような選択位置で心臓の房室内部に創傷(lesion)を形成することに焦点が置かれてきた。
【0016】
意外にも、このような心房期外収縮の1つの発生源が心臓に付随した血管、特に肺静脈、の内部で始まることが判明した。このような心房期外収縮が肺静脈内で形成されてしまうと、これらが周期的に左心房に伝えられる。心房期外収縮が左心房に入ると、これは心房細動のエピソードを開始させるか、または持続することができる。
【0017】
これまでの心房細動の侵襲性治療は、Cox, J.L. et al., Electrophysiology, Pacing and Arrhythmia, 心房細動の手術, Clin. Cardiol., 14, pp. 827-834 (1991)に開示されているような、侵襲性の外科的処置により作られた左心房内の創傷の形成に限られていた。また、肺静脈付近での創傷の形成に使用するために左心房内の適当な位置にアブレーションカテーテルを誘導するための湾曲した誘導導入器の使用が米国特許第5,575,766 号に開示されている。
【0018】
これまでに提案された治療は心房細動の除去には完全には成功していなかったため、これらの処置は一部の患者にはうまくいっても、別の患者では追加の治療が必要になる。さらに、これらの従来のアブレーション処置は非常に時間がかかり、10〜15時間もの時間を必要とする。
【0019】
従って、本発明の1局面は、心房性不整脈、特に心房細動の治療に有用な医療器具を開示することである。
本発明の別の局面は、体内の血管のアブレーション創傷の形成に有用な医療器具を開示することである。
【0020】
本発明のさらに別の局面は、心房性不整脈、特に心房期外収縮の治療のための円周方向アブレーション創傷を形成するのに利用される部品である、一方が他方の内部に位置する一対の膨張可能なバルーンとアブレーション電極とを備えた、医療器具を開示することである。
【0021】
本発明のさらに別の局面は、人体の血管に円周方向アブレーション創傷を形成する方法を開示することである。
本発明のさらに別の局面は、肺静脈内部または肺静脈の口(os)に位置する組織のアブレーション方法を開示することである。
【0022】
本発明のさらに別の局面は、肺静脈内または肺静脈の口 (肺静脈口) に円周方向創傷を形成する方法を開示することである。
本発明のさらに別の局面は、心房細動の治療のために、心血管内部またはそれらの血管の口に円周方向アブレーション創傷を作るための医療処置を開示することである。
【0023】
本発明のさらに別の局面は、高周波(Rf)エネルギーを利用して、心血管内部またはそれらの血管の口にアブレーション創傷を形成する方法を開示することである。
【0024】
本発明の上記およびその他の局面は、本発明の心房性不整脈の治療方法とこの方法で使用するための医療製品の設計に開示されている。
【0025】
【発明の要約】
本発明はヒトの血管の内部またはその血管、特に肺静脈、の口でのアブレーション処置に有用なアブレーションカテーテルである。このカテーテルには第1および第2のバルーンが取り付けられており、第2バルーンは第1バルーンの内部に位置してカテーテルに取り付けられている。これらのバルーンは、膨らませた時に、血管をシールし、バルーンの付近でその血管を通る血液の流れを実質的に妨げる。膨らませた時に第1と第2のバルーン間の空間に導電性媒体を導入するための導入システムもまた、アブレーションカテーテルの1要素として備えられる。第1バルーンはその外面に多数のバルーン穴を有し、それを通って導電性媒体が押し出され、血管の組織と接触する。このアブレーションカテーテルの別の1要素としてアブレーションシステムも備えられ、このシステムは、外側の第1バルーンの内部であるが、内側の第2バルーンの外部に位置でカテーテルに取り付けられる。アブレーションシステムは、1または2以上の高周波エネルギーアブレーション電極を備え、この電極はコイル電極またはリング電極の形態でよい。導電性媒体は、アブレーションシステムからのアブレーション用エネルギーを、第1バルーンのバルーン穴を通って、バルーン穴に隣接した血管内部または血管の口に位置する組織に接触するように伝え、血管内または血管の口に円周方向のアブレーション創傷を形成する。
【0026】
また、本発明は、ヒトの血管の内部またはその血管の口でアブレーションするための医療器具であり、この器具は、前方端部と遠方端部を持ち、その前方端部からその遠方端部まで貫通している内腔を有する、形状付与された誘導導入器と併用して、上述したカテーテルシステムを備えている。この形状付与された導入器は、アブレーション処置を行うために、血管内またはその血管の口の所望位置にアブレーションカテーテルを案内する。
【0027】
ヒトの血管、特に肺静脈内部の組織をアブレーションする方法も開示されており、この方法は、第1と第2のバルーンと電極を備え、第2バルーンが第1バルーンの内部に位置しているアブレーションカテーテルを、血管の内部または血管の口に導入し、第1と第2のバルーンを用いてその血管を通る血液の流れを実質的に阻止するように血管をシールし、第1バルーンの内部から第1バルーンの表面に設けた多数のバルーン穴を通して導電性媒体を送り出し、導電性媒体を利用してアブレーション電極からのエネルギーを、血管内部の組織または血管の口に接触するように伝え、円周方向アブレーション創傷を形成することを含む。
【0028】
【好適態様の詳細な説明】
普通の人の心臓は、右心室、右心房、左心室および左心房を持っている。右心房は上大静脈および下大静脈に流体連通している。房室中隔によって右心房と右心室とが仕切られている。房室中隔内に含まれている三尖弁により、右心房と右心室とが連通している。左心房と接する部分の右心房の内壁に薄肉の凹んだ箇所があり、これが卵円窩である。左心房(11)と各肺静脈(14)への口(os)を持つ心臓の図を図1に示す。
【0029】
正常な心臓では、心筋 (心筋層) の収縮と弛緩は規則正しく起こり、これは電気化学信号が、心筋層内を洞房(SA)結節から房室(AV)結節に伝達され、そこからヒス・プルキンエ(His-Purkinje)系を含む決まった経路に沿って左右の心室に順に流れる結果として起こる。最初の電気刺激はSA結節で発生し、AV結節に伝達される。AV結節は右心房の心房中隔内の冠状静脈洞の開口部付近にある。ヒス・プルキンエ系は、このAV結節から始まり、膜状の心房中隔に沿って三尖弁に向かって進み、房室中隔を通って膜状の心室中隔内に達する。心室中隔のほぼ中間で、ヒス・プルキンエ系は左右に枝分かれし、心室中隔の筋肉部の頂部をまたいでいる。
【0030】
心房性不整脈と呼ばれる異常なリズムが心房内で時に起こる。最も普通の心房性不整脈は、異所性心房頻拍、心房細動、心房粗動の3種類である。心房細動は患者に著しい不快感を生じ、時には死に至ることもある。その理由は、心房細動が次の (1)〜(3) を含む多くの付随する問題を抱えているからである。(1) 不規則な心拍数が患者に不快感と不安感を生ずる、(2) 房室収縮の同期性が失われて心臓の血行が不安定になり、多様なレベルのうっ血性心不全を生ずる、及び(3) 血行の停止 (うっ血) により患者の血栓塞栓症の罹患性が増す。
【0031】
これらの問題を軽減するための従来の試みとしては、薬理学的な治療 (投薬)の利用が目立ち、時に外科的処置も行われてきた。米国特許第5,575,766 号に開示されているように、心房内部で実施されるアブレーション処置により、侵襲的外科手術を行わずに類似の成功を達成することができることが見出された。この非侵襲処置を成功裏に実施するには、アブレーションカテーテルを右心房および左心房内部の所定位置に位置決めして、所定のトラックをアブレーションしなければならない。それにより、再入回路の形成に対する自然の障壁を形成する。
【0032】
心房細動の特異的な病因は十分には解明されていない。意外にも、心房細動、特に発作性心房細動を引き起こすことがある心房期外収縮の1つの発生源が、左心房に付随する肺静脈内に起点があることが発見された。
【0033】
本発明の医療器具の構造を理解するには、心臓内部でそれを使用するための医療処置についてまず理解する必要がある。図2および2Aに示すように、使用時に本発明の医療器具(10)は左心房(11)の中に進められた後、適当な肺静脈(14)の内部またはその肺静脈の口(os)に導入される。 (アブレーション処置は2以上の肺静脈中で必要になることがあることは理解される。しかし、本発明の説明のためには、1つの肺静脈中で行なわれる医療処置に方法を限定する。) アブレーションカテーテル(12)を所定位置に配置した後、これで、肺静脈(14)内の心房期外収縮の発生源を左心房(11)との接続から電気的に孤立させる創傷を作り出す。
【0034】
肺静脈(14)は概ね管状の構造であるが、左心房(11)の中に開くにつれて寸法が増大する。肺静脈(14)から左心房(11)への心房期外収縮の伝達は、心房期外収縮の発生源より手前側の位置での肺静脈(14)の周り、または状況によっては肺静脈口の周りで、円周方向アブレーション創傷を形成することにより完全に停止させることができることが見出された。心房期外収縮の発生源であると考えられる肺静脈(14)の表面の1点をアブレーションするだけでは、心房期外収縮の発生源を左心房(11)から孤立させるのに十分ではないかもしれない。
【0035】
医療従事者が、アブレーション処置が終了する前と後の両方で肺静脈(14)の電気的活動度を監視して、心房期外収縮の発生源を左心房(11)からうまく孤立させたことを確認できるようにすることも重要である。
【0036】
心臓内部での従来のアブレーション処置では、アブレーションカテーテル上に設けた慣用の1個の先端 (チップ) 電極または1もしくは2以上のリング電極を一般に利用する。組織を効果的かつ効率的にアブレーションするため、これらの電極の直径は、通常約5〜8フレンチ (1フレンチは1/3ミリメートル(0.039インチ) に等しい) の範囲内と比較的小さい。肺静脈(14)の直径は約20ミリメートル (0.79インチ) もの大きさになることがあるので、慣用のアブレーションカテーテルに設けた慣用のアブレーション電極を用いて肺静脈(14)の内周に円周方向創傷を形成するのは実際的ではない。
【0037】
肺静脈(14)の内部で円周方向アブレーション創傷を形成する本発明の1態様の工程は、肺静脈(14)を通る血液の流れを防止するために、図2及び2Aに示すように、一方が他方の内部に配置された一対のバルーン(20, 22)を備えたアブレーションカテーテル(12)を、肺静脈(14)の中または肺静脈口の中に導入することを含む。このアブレーションカテーテル(12)はまた、一対のバルーン(20, 22)の内部に位置するようにカテーテル(12)に取り付けられた、組織をアブレーションするためのアブレーションシステムも備える。最後に、肺静脈(14)の中または肺静脈口の組織を心房期外収縮の発生源より手前の位置でアブレーションし、円周方向創傷を形成する。
【0038】
第1の好適態様では、図2〜9に示すように、医療器具(10)は、第1バルーン(20)および第2バルーン(22)が取り付けられているカテーテル(12)を備える。本発明の第1の態様のカテーテル(12)は、図3および5に示すように、前方端部(16)および遠方端部(18)を含む。カテーテル(12)の材料は従来のものであり、カテーテル(12)を血管構造を通して心臓に入れ、心臓の房室を横断して最後に肺静脈(14)の中まで進めることができるように十分に柔軟なものとすべきである。カテーテル(12)の遠方部分(16)はカテーテル(12)の残りの部分より柔軟性を大きくしてもよいが、カテーテル(12)の柔軟性はカテーテル(12)の全長を通して一定としてもよい。柔軟性の増大は、当業界で周知の常套手段により達成することができる。血管構造および心臓の房室を通るカテーテル(12)の前進を助けるため、カテーテル(12)の主要部分をカテーテル(12)の遠方部分に比べて剛性を高くし、柔軟性を小さくしてもよい。1態様において、この主要部分は、形状記憶性を持つ、即ち、その所望形状からの変形とその後の所望形状への実質的な復帰が可能である、任意の慣用のカテーテル材料から形成することができる。この主要部分は、例えば、補強用ブレードまたは他のこのような高い一時的強度(temporal strength) を持った適当なストランド材料を用いて、補強してもよい。カテーテルの遠方部分の柔軟性を増大させるのは、カテーテル(12)の補強部分に存在するのと類似の性能特性を持った同一または類似材料からなる、融着フレキシブルチップカテーテルまたはソフトチップドカテーテルの使用をはじめとする、当業界で周知の多くの方法により達成することができる。また、より柔軟性の高いカテーテル(12)の遠方部分は、カテーテル本体をさらに延伸してその肉厚を減少させ、柔軟性の増大を得るといった、カテーテル(12)内で行われる変形により作り出すこともできる。
【0039】
カテーテル(12)の全長は約50〜150 cm (20〜約60インチ) とするのがよい。
カテーテル(12)は、カテーテル(12)の前方端部(16)からカテーテル(12)の遠方端部(18)またはその付近まで通っている複数の慣用の内腔も備えていることが好ましい。1好適態様において、カテーテル(12)は、少なくとも4本の別々の内腔を備える。第1の内腔は、カテーテル(12)の前方端部(16)から遠方端部(18)まで達しており、カテーテル(12)の遠方端部(18)の遠方開口(32)で終わっている。この内腔は、カテーテル(12)を肺静脈(14)の内部に誘導する際にカテーテル(12)に通すガイドワイヤーを収容するためのものである。この内腔はまた、アブレーション処置中にカテーテル(12)のバルーン(20, 22)から遠方側の位置で肺静脈(14)に対比媒体(contrast media)を導入するのにも使用することができる。カテーテル(12)の第2の内腔は、カテーテルの前方端部(16)からカテーテル(12)の遠方端部(18)付近に位置する1または2以上の電極(30)にまで達している電極導電線を収容する。第3の内腔は、内側の第2バルーン(22)の中に導電性媒体を導入するためのものである。この媒体は、内側の第2バルーン(22)を膨らませるのに利用される。この位置での媒体の導入のために、図6および7に示すように、内側の第2バルーン(22)の内部の位置でカテーテル(12)に穴(24)が形成されている。第4の内腔は、外側の第1バルーン(20)の内部に導電性媒体、好ましくは塩類溶液を導入するためのものである。この導電性バインダーを受けるために、図6および7に示すように、好ましくは内側の第2バルーン(22)より前方側と遠方側の両側で、かつ第1バルーン(20)の内部になる位置で、カテーテル(12)に媒体導入穴(26)が設けてある。この導電性媒体は、カテーテル(12)に装着された電極(30)からのエネルギーを、外側バルーン(22)の表面(34)に設けたバルーン穴(28)を経て肺静脈(14)の内面に接触するように伝えるためのものである。カテーテル(12)には、他の慣用の利用のためにさらに別の内腔を設けてもよい。
【0040】
本発明はまた、導電性媒体を外側の第1バルーン(20)の内部の空間に導入するための導入システムと、第1バルーン(20)の内部であるが、第2バルーン(22)のの外側の位置でカテーテル(12)の外面(13)に取り付けられたアブレーションシステムもまた包含する。円周方向アブレーション創傷の形成を助けるため、例えば、心房期外収縮の存在を感知するためのセンサー (図示せず) 、アブレーションする組織の温度を感知するための温度センサー (図示せず) 、肺静脈(14)内部でのカテーテル(12)やその部品の位置をマークするためのマーカー (図示せず) 、およびアブレーションカテーテル(12)に普通に利用されている他の慣用の部品、を包含する、他の部品をカテーテル(12)に取り付けてもよい。
【0041】
2つのバルーン(20, 22)は、図3〜8に示す通り、カテーテル(12)の外面(13)に装着されている。外側の第1バルーン(20)の大きさは、典型的には、長さ約10 mm(0.4 in) ないし約100 mm(4.0 in)で、図5、6および7に示すように、開いた時には一般に楕円形の形状をとる。完全に膨らませた時の外側の第1バルーン(20)の最大直径は約60 mm(2.4 in) までの範囲で変動可能である。内側の第2バルーン(22)もカテーテル(12)の外面(13)に装着され、その装着 (取付け) 位置は、図5、6および7に示すように、外側の第1バルーン(20)の内部である。膨らませた時に、内側の第2バルーン(22)の大きさは、長さが約2mm(0.1 in)ないし約100 mm(4.0 in)、好ましくは約5mm(0.2 in)ないし約20 mm(0.8 in) であり、直径は外側の第1バルーン(20)とほぼ同じである。図5、6および7に示すように、内側の第2バルーン(22)の膨張が、外側の第1バルーン(20)の膨張も生じて、アブレーション処置中を通して外側バルーン(20)をその膨らませた状態に保持することが好ましい。
【0042】
バルーン(20, 22)は、軟質または熱可塑性ゴム、ウレタン、ラテックス、セルロースまたは他の慣用材料といった材料から慣用技術に従って製造され、カテーテル(12)に常法により装着される。
【0043】
バルーン(20, 22)の膨張は、常法により、好ましくは放射線不透過性の対比溶液、より好ましくはマークされた塩類溶液、を用いて行われる。また、所望により、放射線不透過性のマーカー帯 (図示せず) を外側の第1バルーン(20)の表面(34)に装着し、肺静脈(14)内でのその相対的な位置をマークしてもよい。肺静脈(14)内または肺静脈口での適正な位置が決まったら、カテーテル(12)をその位置から少しだけ引き戻して、その後で形成される円周方向アブレーション創傷が期外心房収縮の発生源より手前側に位置するようにしてもよい。
【0044】
バルーン(20, 22)は、適切に膨らませた時に、これらのバルーン(20, 22)の周囲で肺静脈(14)を通る血液の流れを完全に阻止するようにすべきである。バルーン(20, 22)は内側の第2バルーン(22)の内部に設けた穴(24)から媒体を導入することにより膨らませることが好ましく、それにより内側バルーン(22)と外側バルーン(20)の両方を膨らませる。これに代えて、または加えて、外側バルーン(20)の内部でカテーテル(12)に設けた媒体導入穴(26)から別の媒体を導入して、その膨張を助けてもよい。バルーン(20, 22)が確実に肺静脈(14)内の緊密なシールを形成するのを確保するため、カテーテル(12)の遠方側の先端(18)に設けた遠方先端開口(32)から対比媒体を注入してもよい。もし漏れが発見された場合には、バルーン(20, 22)が肺静脈(14)内の血液の流れを完全に停止させるまで追加の媒体を内側バルーン(22)の中に導入することができる。
【0045】
バルーン(20, 22)を適正に膨らませたら、内側の第2バルーン(22)より前方側 (手前側) および遠方側の位置でカテーテル(12)の外面(13)に設けた媒体導入穴(26)から、導電性媒体を外側バルーン(20)の内部に導入する。図6および7に示すように、2つのこのような媒体導入穴(26)を内側の第2バルーン(22)より前方側と遠方側の両方の位置でカテーテル(12)に設けることが好ましい。1態様において、導電性媒体は、蛍光透視法により監視できるようにマーカーでマークした塩類溶液であるが、任意の適当な導電性媒体を使用することができる。
【0046】
バルーン穴(28)が、例えば、図6および7に示すように、外側の第1バルーン(20)の表面(34)に設けられる。1好適態様において、これらのバルーン穴(28)は、外側の第1バルーン(20)の表面(34)を一周する一連の直線状に形成される。これらのバルーン穴(28)は、1本の線状に形成されていてもよいが、好適態様では、図6および7に示すように、これらのバルーン穴は、それぞれ外側の第1バルーン(20)の表面(34)を完全に一周して走る2本以上の線を形成する。
【0047】
別の1態様において、これらの線状のバルーン穴(28)は、図8に示すように、外側の第1バルーン(20)の中で、内側の第2バルーン(22)より遠方側の位置だけに設ける。この別の構造は、導電性媒体を、左心房(11)中に消散させずに、肺静脈(14)内で内側バルーン(22)より遠方側に集中させて組織表面に当てるようにすることができる。
【0048】
外側の第1バルーン(20)の内部であるが、内側の第2バルーン(22)の外部に配置した電極(30)は、好ましくは高周波エネルギーを発生する。この高周波エネルギーは、導電性媒体によって、外側の第1バルーン(20)の表面(34)に設けたバルーン穴(28)から肺静脈(14)の内部の組織に伝えられる。これらのバルーン穴(28)は外側の第1バルーン(20)の表面(34)を一周する1または2以上の線状に形成されているので、電極(30)により発生した導電性エネルギーは、肺静脈(14)の内部で円周方向の創傷を形成する。
【0049】
アブレーションエネルギーの好ましい供給源は高周波エネルギーであるが、マイクロ波、超音波または熱といった他のエネルギー源も利用できる。アブレーション処置中、カテーテル(12)からのエネルギーは導電性媒体によって肺静脈(14)の内部の組織に伝えられる。1好適態様において、組織が導電性媒体より速い速度でアブレーション温度まで昇温するように、導電性媒体のインピーダンスはヒトの組織のインピーダンスより小さくすべきである。
【0050】
アブレーションシステムは、図6および7に示すように一対のコイル電極(30)から、または図9および10に示すように一対のリング電極(130) から構成することができる。1好適態様において、2つの電極は、コイル(30)とリング(130) のいずれでも、一方が内側バルーン(22)より前方 (手前) 側、他方がそれより遠方側で、どちらも外側バルーン(20)の内部にくる位置で、カテーテル(12)に装着される。
【0051】
アブレーション創傷の形成を監視するため、サーミスタまたは熱電対のような温度センサー (図示せず) をカテーテル(12)の外面(13)に取り付けてもよい。肺静脈の電気的活動度を監視するために感知用電極 (図示せず) を任意の適当な位置でカテーテル(12)に取り付けることもできる。
【0052】
操作に際しては、医療器具(10)の体内への挿入には普通は修正セルディンガー(Seldinger) 法が採用される。この方法を用いた場合、カテーテルや拡張器を通り易くするため、適当な位置に小さな皮膚切開を行う。次いで、皮下組織を切開した後、比較的浅い角度に位置させたスタイレットつきの適当な針で血管を穿刺する。針を次いで不完全に引抜き、やや異なる角度で再び血管に挿入して、針が確実に血管内にとどまるようにする。次いで、適当な寸法のガイドワイヤーの柔軟な可撓性の先端を、針の中を通して針より少し先まで血管内に挿入する。ガイドワイヤーをその位置にしっかり保持したまま針を取り出し、ガイドワイヤーの一部は血管の外部に露出したままとする。ガイドワイヤーを次いで右大腿静脈まで進め、さらに下大静脈を経て右心房に入れる。(好ましい処置法では左右の心房に下方から接近させる。左心房への逆行接近処置および上方からの接近処置も採用でき、本発明の範囲内である。)次いで、ガイドワイヤーを所定位置に保持したまま、拡張器を導入器と共にガイドワイヤーの周囲に通す。拡張器と導入器は一般に組立体 (アセンブリ) を形成し、一緒にガイドワイヤーに沿って下大静脈の中まで進められる。導入器は従来の直線状の導入器でもよいが、好ましくはデイグ・コーポレーションから販売されているSL2 導入器のような予め湾曲させてある導入器がよい。
【0053】
その後、ブロッケンブロー (Brockenbrough)針またはトロカール (套管針) を拡張器の内腔を通して右心房まで挿入し、好ましくは卵円窩にて、心房中隔を貫通する開口を形成するのに使用する。この器具全体(拡張器、導入器およびブロッケンブロー針)を大静脈から右心房内に進ませ、先端が卵円窩のレベルで心房中隔に当たった状態にする。次いで、ブロッケンブロー針を卵円窩を通過させて前進させる。心房中隔を貫通する開口を作ったのち、ブロッケンブロー針をガイドワイヤーと交換する。拡張器とガイドワイヤーと左心房用の誘導導入器を左心房の中まで進める。その後、拡張器を取り出して、導入器とガイドワイヤーを左心房内の適所に残す。次いで、アブレーションカテーテル(12)を、ガイドワイヤーの周りに通して、導入器の内腔の中を前進させ、左心房の中まで進める。その後、ガイドワイヤーを操縦して、これが適正な肺静脈(14)の中に入るようにする。次に、ガイドワイヤーを中に通したカテーテル(12)を肺静脈の中まで前進させ、ガイドワイヤーを取り出す。
【0054】
アブレーションカテーテル(12)の遠方端部(16)を肺静脈(14)の中まで前進させたら、カテーテル(12)の遠方端部(16)またはその付近に取り付けられた感知用電極 (図示せず) を用いてカテーテルを位置決めしてもよい。この感知用先端電極は、心房期外収縮を含む、肺静脈(14)の内部の電気的活動度を感知する。心房期外収縮の発生源が内側バルーン(22)および外側バルーン(20)より遠方であることを確認したら、カテーテル(12)の媒体導入穴(26)から媒体を導入して内側バルーン(22)を膨らませる。内側バルーン(22)を膨らませると、外側バルーン(20)も膨らむ。この内側バルーン(22)と外側バルーン(20)は、これらのバルーン(20, 22)の周囲での肺静脈(14)を通る血液の流れを完全に阻止するように十分に膨らませなければならない。このバルーン(20, 22)の周囲で血液が全く流れないのを確実にするため、マークされた媒体を、バルーン(20, 22)より遠方の地点で、例えば、カテーテル(12)の遠方側の先端(18)に設けた先端開口(32)から、肺静脈(14)の中に注入してもよい。その後、バルーン(20, 22)の周囲での漏れの有無を蛍光透視法で判定し、漏れがある場合には、内側バルーン(22)の内部に追加の圧力を加えて漏れを解消することができる。
【0055】
その後、アブレーションシステム、好ましくは、外側バルーン(20)の内部で、内側バルーン(22)の外部の位置でカテーテル(12)の外面(13)に装着された一対の高周波コイル電極(30)またはリング電極(130) 、がエネルギーを発生し、このエネルギーが、導電性媒体により、外側バルーン(20)の表面(34)のバルーン穴(28)を経て肺静脈(14)の組織の表面に伝えられる。肺静脈(14)を通る心房期外収縮の伝達を完全に遮断するのに十分な幅と深さの円周方向創傷を作るように十分なエネルギーを発生させる。肺静脈(14)の組織の温度を、2つのバルーン(20, 22)の外部の位置でカテーテル(12)の表面13) に装着された、サーミスタまたは熱電対のような温度センサー (図示せず) により監視してもよい。また、感知用電極 (図示せず) をバルーン(20, 22)より手前側に配置して、アブレーション処置が終了した後の血管を通る電気的活動度を感知し、肺静脈(14)の完全な遮断を確実にしてもよい。アブレーションすべき組織は、肺静脈(14)の内部または肺静脈(14)の口における任意の位置でよい。
【0056】
アブレーション処置が終了し、感知用電極を用いて試験した後、本システムの各要素を肺静脈(14)および左心房(11)から取り出す。所望により、別の感知用器具を左心房(11)に導入して、他の肺静脈(14)に心房期外収縮の他の発生源がさらにあるかどうかを決定することができる。
【0057】
本発明の特定の形態を以上に例示および説明したが、本発明の技術思想および範囲を逸脱せずに各種の変更をなしうることは以上から明らかであろう。例えば、本発明は冠状静脈洞および他の静脈といった他の血管内または脈管でのアブレーション処置に使用することもできる。
【図面の簡単な説明】
【図1】 左心房と4つの肺静脈を示す心臓の破断図。
【図2】 肺静脈の1つに導入された本発明のアブレーションカテーテルを示す左心房の破断図。
【図2A】 肺静脈の1つに導入された本発明のアブレーションカテーテルの破断図。
【図3】 バルーンが膨らんでいない本発明のアブレーションカテーテルの斜視図。
【図4】 バルーンが膨らんでいない図3のアブレーションカテーテルの遠方部分の斜視図。
【図5】 バルーンを膨らませた図3のアブレーションカテーテルの破断斜視図。
【図6】 バルーンを膨らませた図5のアブレーションカテーテルの遠方部分の破断斜視図。
【図7】 バルーンを膨らませた図5のアブレーションカテーテルの遠方部分の破断側面図。
【図8】 外側の第1バルーンのバルーン穴の位置について別の態様を示す、バルーンを膨らませたアブレーションカテーテルの遠方部分の破断側面図。
【図9】 コイル電極の代わりにリング電極を設けた、図7のアブレーションカテーテルの別の態様の破断斜視図。
【図10】 図9のアブレーションカテーテルの別の態様の遠方部分の破断側面図。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to medical devices and methods useful for the treatment of atrial arrhythmias. In particular, the present invention relates to preferred methods and medical devices for use in ablation procedures in human blood vessels, ie, pulmonary veins.
[0002]
Introducers and catheters have been used for many years in medical procedures. For example, one procedure using a catheter is to transmit electrical stimulation to a specific site within the human body. Another procedure using a catheter is to monitor activity (degrees) at various sites in the body for diagnostic testing. That is, the catheter can be positioned at a specific site in the body that cannot be accessed unless a more highly invasive treatment is performed by other methods, and during that time, examination, diagnosis, and treatment can be performed. In use, the catheter may be inserted into a major vein or artery close to the body surface. Thereafter, the catheter is manipulated through an artery or vein in the body to guide it to a specific site for examination, diagnosis or treatment. This catheter manipulation is often performed with the help of other medical devices such as introducers or guide wires.
[0003]
One common medical procedure that utilizes special catheters is the treatment of blood vessels placed inside the human body, most often blood vessels associated with the human heart. Such a procedure, the most prominent example being an angioplasty, utilizes a catheter, which is often fitted with an inflatable balloon. In some of these types of medical procedures, the catheter includes a pair of (two) inflatable balloons that limit the portion of the blood vessel that is treated, or the catheter remains throughout the medical procedure. Used to ensure that it stays in a fixed position inside the blood vessel or to help perform a medical procedure.
[0004]
Multiple balloon catheters are used throughout the body. For example, US Pat. No. 5,468,239 discloses a device for circumferential laser ablation of the urethra. The instrument utilizes a pair of cuffs or balloons (60) and includes a laser probe (12) disposed between the balloons. U.S. Pat. No. 5,588,961 discloses an infusion catheter for dispensing medication into a blood vessel, which includes a pair of balloons (16, 17) and electrodes (35) attached thereto. This catheter is provided with a mouth for introducing a medicine into the space between two balloons inside the blood vessel. Energy may be introduced into the electrode to facilitate the movement of the medicament away from the catheter and toward the vessel wall. U.S. Pat. No. 5,256,141 discloses a pair of balloons (14, 18) with electrodes attached to a catheter. This electrode is for applying a controlled charge to the material introduced into the space in the blood vessel between the two balloons.
[0005]
Biological material may be introduced into this space for medical treatment of blood vessels. US Pat. No. 5,366,490 discloses a pair of balloons (30, 32) and a stylet (36) attached to a catheter. Radio frequency energy is supplied to the catheter to destroy the tissue. US Pat. No. 5,599,307 discloses a pair of balloons (41, 42) attached to a catheter designed to occlude a blood vessel. U.S. Pat. No. 5,002,532 discloses a pair of balloons (21, 22) attached to a catheter (12) for use in dilatation procedures within blood vessels, where the two balloons can be inflated to different levels. Good. U.S. Pat. No. 5,792,105 discloses a multi-channel balloon catheter for delivering fluid using an inner balloon and an outer balloon. See also US Pat. No. 4,445,892.
[0006]
In addition to the use of multiple balloons on a single catheter for medical procedures, U.S. Pat.No. 5,462,529 discloses a medical device with a pair of catheters (12, 28), each catheter comprising: A single balloon (20, 48) attached at or near its distal end (distant end) is used to perform medical procedures inside the blood vessel. U.S. Pat. No. 5,484,412 also discloses a pair of catheters (18, 22), each with an inflatable balloon (36, 38) utilized to perform a medical procedure inside a blood vessel. U.S. Pat. No. 4,911,163 discloses a pair of balloons (2, 8) attached to a pair of catheters (1, 7), which introduces a pharmaceutical or diagnostic fluid into the space between the two balloons. Is for.
[0007]
Atrial fibrillation is the most common sustained arrhythmia. It is estimated that this is almost 0.4% of the adult population, and probably about 10% in the population over 60 years old. Cox, J.L. et al.,Electrophysiology, pacing and arrhythmia (Electrophysiology, Pacing and Arrhythmia), "Operations for Atrial Fibrillation",Clin. Cardiol.14, 827-834 (1991).
[0008]
Atrial arrhythmias are both transient and persistent. Many atrial arrhythmias occur in those with another underlying form of heart disease, but some atrial arrhythmias occur independently. Atrial arrhythmia is less likely to lead to death than ventricular arrhythmia, but increases the risk factors for many other diseases, such as systemic and cerebral embolism, and causes many additional medical problems There is.
[0009]
In the treatment of atrial arrhythmia, relief may sometimes be obtained with antiarrhythmic drugs. Another treatment for atrial arrhythmia or fibrillation is to use a defibrillator or cardioversion implanted in the body. For example, U.S. Pat.Nos. 5,282,836, 5,271,392 and 5,209,229, and Martin D., et al.,Atrial fibrillation (Atrial Fibrillation), pp. 42-59 (1994).
[0010]
However, some patients with symptomatic or life-threatening atrial arrhythmias cannot be adequately treated with drugs or medical devices of the above type. In that case, other forms of aggressive treatment were required, which in the past often included surgery. For example, a surgical procedure for the treatment of atrial arrhythmias called the `` Maze '' method is Cox, J.L. et al.,Electrophysiology, Pacing and ArrhythmiaAtrial fibrillation surgery,Clin. Cardiol., Vol.14, pp.827-834 (1991).
[0011]
Another treatment that has increased use within the last 10-15 years for the treatment of certain cardiac arrhythmias involves ablation of heart tissue. For example, this procedure has been commonly used to interrupt or deform existing conduction pathways associated with arrhythmias within the heart. The specific site for ablation depends on the underlying arrhythmia type. The use of radiofrequency catheter ablation for the treatment of paroxysmal atrial fibrillation has been described by Haissaguerre, M. et al., “Right and Left Atrial Radiofrequency Catheter Therapy of Paroxysmal Atrial Fibrillation)J. Cardiovascular Electrophysiology, V.7, pp. 1132-1144 (December 1996). Ablation procedures are also used to treat atrioventricular (AV) nodule reentrant tachycardia. With this condition, ablating the fast or slow AV nodal pathway has become an acceptable treatment. Singer, I., et al., “Catheter Ablation for Arrhythmias”Clinical manual of electrophysiology (Clinical Manual of Electorophysiology) pp. 421-431 (1993); Falk, R.H., et al.,Atrial fibrillation management mechanism (Atrial Fibrillation Mechanisms in Management), pp.359-374 (1992); Horowitz, L.N.,Latest arrhythmia management (Current Management of Arrhythmias), pp.373-378 (1991); and Martin, D., et al.,Atrial fibrillation (Atrial Fibrillation), pp. 42-59 (1994). The use of ablation catheters to ablate the location within the heart is also disclosed, for example, in US Pat. Nos. 4,641,649, 5,263,493, 5,231,995, 5,228,442, and 5,281,217.
[0012]
The energy sources used for catheter ablation are diverse. In the early days, the high-voltage direct current (DC) ablation method was generally adopted. However, due to problems associated with the use of direct current, radio frequency (Rf) energy has become a preferred energy source for ablation procedures. Ablation using high frequency energy is disclosed, for example, in U.S. Pat. Nos. 4,945,912, 5,209,229, 5,281,218, 5,242,441, 5,246,438, 5,281,213, and 5,293,868. Other energy sources currently used or contemplated for ablation of heart tissue include lasers, ultrasound, microwaves, and fulgutronization.
[0013]
In order to ablate the exact location within the heart, the ablation catheter must be accurately positioned within the heart. Accurate positioning of the ablation catheter is particularly difficult in view of the physiological function of the heart, particularly because ablation procedures are generally performed while the heart is beating. In general, catheter placement is determined by a combination of electrophysiological guidance and X-ray (fluorescence) fluoroscopy (known anatomical structures such as coronary sinus, high right atrium, and right ventricle). Placement of the catheter relative to a known characteristic site of the heart marked by a radiopaque diagnostic catheter placed inside or on the surface of the heart).
[0014]
Atrial arrhythmia mapping and treatment methods using ablation catheters guided to specific locations by a shaped guiding introducer are described in U.S. Patent Nos. 5,427,119, 5,497,774, 5,575,766, and 5,564,440. No. 5,628,316 and 5,640,955. In particular, as a component of the treatment of atrial fibrillation, a method for ablation of a defined track within the left atrium and / or right atrium is disclosed in US Pat. No. 5,575,766.
[0015]
The onset mechanism of certain forms of atrial arrhythmia, such as pre-atrial (early) contraction, is not well understood. As a result, intracardiac ablation procedures may prevent the passage of electrical signals associated with pre-atrial contractions or prevent the formation of inappropriate electrical pathways within the heart that may cause atrial arrhythmias. The focus has been on creating a lesion within the chamber of the heart at selected locations.
[0016]
Surprisingly, it has been found that one source of such an atrial premature contraction begins within the blood vessels associated with the heart, particularly the pulmonary veins. If such atrial premature contractions are formed in the pulmonary veins, they are periodically transmitted to the left atrium. As an atrial extrasystole enters the left atrium, it can initiate or persist an episode of atrial fibrillation.
[0017]
Previous invasive treatment of atrial fibrillation has been described by Cox, J.L. et al.,Electrophysiology, Pacing and ArrhythmiaAtrial fibrillation surgery,Clin. Cardiol., 14, pp. 827-834 (1991), and was limited to the formation of wounds in the left atrium created by invasive surgical procedures. US Pat. No. 5,575,766 discloses the use of a curved lead introducer to guide an ablation catheter to an appropriate location within the left atrium for use in forming a wound near the pulmonary vein.
[0018]
Previously proposed therapies have not been completely successful in removing atrial fibrillation, so these treatments work well for some patients but others require additional treatment . Furthermore, these conventional ablation procedures are very time consuming and require as much as 10-15 hours.
[0019]
Accordingly, one aspect of the present invention is to disclose a medical device useful for the treatment of atrial arrhythmias, particularly atrial fibrillation.
Another aspect of the present invention is to disclose a medical device useful for the formation of ablation wounds of blood vessels in the body.
[0020]
Yet another aspect of the present invention is a pair of components utilized to form a circumferential ablation wound for the treatment of atrial arrhythmias, particularly pre-atrial contraction, one pair located within the other. Disclosed is a medical device comprising an inflatable balloon and an ablation electrode.
[0021]
Yet another aspect of the present invention is to disclose a method of forming a circumferential ablation wound in a blood vessel of a human body.
Yet another aspect of the present invention is to disclose a method for ablation of tissue located within the pulmonary vein or in the mouth (os) of the pulmonary vein.
[0022]
Yet another aspect of the present invention is to disclose a method of forming a circumferential wound in the pulmonary vein or in the mouth of the pulmonary vein (pulmonary vein mouth).
Yet another aspect of the present invention is to disclose a medical procedure for creating a circumferential ablation wound within the cardiovascular or mouth of those vessels for the treatment of atrial fibrillation.
[0023]
Yet another aspect of the present invention is to disclose a method of utilizing a radio frequency (Rf) energy to form an ablation wound within a cardiovascular or mouth of those vessels.
[0024]
These and other aspects of the present invention are disclosed in the method of treating atrial arrhythmias of the present invention and the design of medical products for use in this method.
[0025]
SUMMARY OF THE INVENTION
The present invention is an ablation catheter useful for ablation treatment in the mouth of human blood vessels or in the blood vessels, particularly pulmonary veins. First and second balloons are attached to the catheter, and the second balloon is located inside the first balloon and attached to the catheter. These balloons, when inflated, seal the blood vessel and substantially impede blood flow through the blood vessel in the vicinity of the balloon. An introduction system for introducing a conductive medium into the space between the first and second balloons when inflated is also provided as an element of the ablation catheter. The first balloon has a number of balloon holes on its outer surface, through which the conductive medium is extruded and contacts the vascular tissue. An ablation system is also provided as another element of the ablation catheter, which is attached to the catheter at a location inside the outer first balloon but outside the inner second balloon. The ablation system comprises one or more radio frequency energy ablation electrodes, which may be in the form of coil electrodes or ring electrodes. The conductive medium conveys the ablation energy from the ablation system through the balloon hole of the first balloon and into contact with tissue located within the blood vessel adjacent to the balloon hole or at the mouth of the blood vessel. A circumferential ablation wound is formed in the mouth.
[0026]
The present invention is also a medical device for ablation inside a human blood vessel or at the mouth of the blood vessel, the device having a front end and a far end, from the front end to the far end. The catheter system described above is provided in combination with a shaped guide introducer having a lumen therethrough. This shaped introducer guides the ablation catheter into the blood vessel or a desired location in the mouth of the blood vessel to perform the ablation procedure.
[0027]
Also disclosed is a method of ablating human blood vessels, particularly tissue inside a pulmonary vein, comprising a first and a second balloon and an electrode, the second balloon being located inside the first balloon. An ablation catheter is introduced into the interior of the blood vessel or into the mouth of the blood vessel, and the first and second balloons are used to seal the blood vessel so as to substantially prevent blood flow through the blood vessel; The conductive medium is sent out through a number of balloon holes provided on the surface of the first balloon from the first balloon, and the energy from the ablation electrode is transmitted using the conductive medium so as to contact the tissue inside the blood vessel or the mouth of the blood vessel. Forming a circumferential ablation wound.
[0028]
[Detailed Description of Preferred Embodiments]
The normal human heart has a right ventricle, a right atrium, a left ventricle, and a left atrium. The right atrium is in fluid communication with the superior and inferior vena cava. The right atrium and right ventricle are partitioned by the atrioventricular septum. The right atrium communicates with the right ventricle by a tricuspid valve contained within the atrioventricular septum. There is a thin-walled concave portion on the inner wall of the right atrium that is in contact with the left atrium, which is the oval fossa. A diagram of the heart with the left atrium (11) and the mouth (os) to each pulmonary vein (14) is shown in FIG.
[0029]
In a normal heart, contraction and relaxation of the myocardium (myocardium) occurs regularly, and this is because electrochemical signals are transmitted through the myocardium from the sinoatrial (SA) node to the atrioventricular (AV) node, from which His Purkinje Occurs as a result of sequential flow to the left and right ventricles along a fixed path involving the (His-Purkinje) system. The first electrical stimulation occurs in the SA node and is transmitted to the AV node. The AV node is near the opening of the coronary sinus in the atrial septum of the right atrium. The His-Purkinje system begins with this AV node, progresses along the membranous atrial septum toward the tricuspid valve, passes through the atrioventricular septum, and reaches the membranous ventricular septum. In the middle of the ventricular septum, the His-Purkinje system branches to the left and right and straddles the top of the muscular part of the ventricular septum.
[0030]
An abnormal rhythm called atrial arrhythmia sometimes occurs in the atria. The three most common atrial arrhythmias are ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Atrial fibrillation causes significant discomfort to the patient and can sometimes be fatal. The reason is that atrial fibrillation has many accompanying problems including the following (1) to (3). (1) Irregular heart rate causes patient discomfort and anxiety, (2) Loss of synchrony of atrioventricular contractions, destabilizing heart circulation, and various levels of congestive heart failure And (3) Suspension of blood circulation (congestion) increases the patient's susceptibility to thromboembolism.
[0031]
Conventional attempts to alleviate these problems have been conspicuous in the use of pharmacological treatment (medication), and sometimes surgical procedures have also been performed. As disclosed in US Pat. No. 5,575,766, it has been found that ablation procedures performed within the atria can achieve similar success without invasive surgery. To successfully perform this non-invasive procedure, the ablation catheter must be positioned in place within the right and left atria to ablate a given track. This creates a natural barrier to the formation of the reentry circuit.
[0032]
The specific etiology of atrial fibrillation has not been fully elucidated. Surprisingly, it has been discovered that one source of atrial premature contractions that can cause atrial fibrillation, particularly paroxysmal atrial fibrillation, originates in the pulmonary veins associated with the left atrium.
[0033]
To understand the structure of the medical device of the present invention, it is first necessary to understand the medical procedure for using it inside the heart. As shown in FIGS. 2 and 2A, in use, the medical device (10) of the present invention is advanced into the left atrium (11) and then into the appropriate pulmonary vein (14) or the mouth of the pulmonary vein (os ). (It is understood that an ablation procedure may be required in more than one pulmonary vein. However, for purposes of illustrating the present invention, the method is limited to medical procedures performed in one pulmonary vein. ) After placing the ablation catheter (12) in place, this creates a wound that electrically isolates the source of pre-atrial contraction in the pulmonary vein (14) from connection with the left atrium (11).
[0034]
The pulmonary vein (14) is a generally tubular structure, but increases in size as it opens into the left atrium (11). The transmission of extraatrial contraction from the pulmonary vein (14) to the left atrium (11) can be transmitted around the pulmonary vein (14) at a position in front of the origin of the extraatrial contraction, or depending on the situation, It has been found that it can be stopped completely by forming a circumferential ablation wound. Ablating only one point on the surface of the pulmonary vein (14), which is considered to be the source of pre-atrial contraction, may not be sufficient to isolate the source of pre-atrial contraction from the left atrium (11) unknown.
[0035]
The health care professional successfully monitored the electrical activity of the pulmonary veins (14) both before and after the ablation procedure was completed, and successfully isolated the source of pre-atrial contraction from the left atrium (11) It is also important to be able to confirm.
[0036]
Conventional ablation procedures inside the heart typically utilize a conventional tip (tip) electrode or one or more ring electrodes provided on an ablation catheter. In order to ablate tissue effectively and efficiently, the diameter of these electrodes is relatively small, typically in the range of about 5-8 French (one French equals 1/3 millimeter (0.039 inch)). The diameter of the pulmonary vein (14) can be as large as about 20 millimeters (0.79 inches), so use the conventional ablation electrode on a conventional ablation catheter to circle the inner circumference of the pulmonary vein (14). It is not practical to form a directional wound.
[0037]
The process of one embodiment of the present invention for forming a circumferential ablation wound within the pulmonary vein (14) is shown in FIGS. 2 and 2A to prevent blood flow through the pulmonary vein (14), as shown in FIGS. Introducing an ablation catheter (12) with a pair of balloons (20, 22), one disposed within the other, into the pulmonary vein (14) or into the pulmonary vein port. The ablation catheter (12) also includes an ablation system for ablating tissue that is attached to the catheter (12) to be positioned within a pair of balloons (20, 22). Finally, the tissue in the pulmonary vein (14) or at the pulmonary vein mouth is ablated at a location in front of the source of pre-atrial contraction to form a circumferential wound.
[0038]
In the first preferred embodiment, as shown in FIGS. 2-9, the medical device (10) comprises a catheter (12) to which a first balloon (20) and a second balloon (22) are attached. The catheter (12) of the first aspect of the present invention includes a forward end (16) and a distal end (18) as shown in FIGS. The material of the catheter (12) is conventional and sufficient to allow the catheter (12) to enter the heart through the vasculature and traverse the heart chamber and finally into the pulmonary vein (14). Should be flexible. The distal portion (16) of the catheter (12) may be more flexible than the rest of the catheter (12), but the flexibility of the catheter (12) may be constant throughout the length of the catheter (12). Increased flexibility can be achieved by conventional means well known in the art. To help advance the catheter (12) through the vasculature and the heart chamber, the main part of the catheter (12) may be stiffer and less flexible than the distal part of the catheter (12) . In one embodiment, the main portion can be formed from any conventional catheter material that has shape memory, ie, can be deformed from its desired shape and subsequently substantially restored to its desired shape. it can. This main part may be reinforced with, for example, a reinforcing blade or other suitable strand material having such a high temporal strength. Increasing the flexibility of the distal portion of the catheter can be achieved by using a fused flexible tip catheter or soft tip catheter made of the same or similar material with similar performance characteristics as present in the reinforced portion of the catheter (12). This can be accomplished by a number of methods well known in the art, including use. Also, the distal part of the more flexible catheter (12) is created by deformations made in the catheter (12), such as further stretching the catheter body to reduce its wall thickness and gain increased flexibility. You can also.
[0039]
The total length of the catheter (12) may be about 50 to 150 cm (20 to about 60 inches).
The catheter (12) preferably also includes a plurality of conventional lumens that run from the forward end (16) of the catheter (12) to or near the distal end (18) of the catheter (12). In one preferred embodiment, the catheter (12) comprises at least four separate lumens. The first lumen extends from the forward end (16) of the catheter (12) to the distal end (18) and ends with the distal opening (32) of the distal end (18) of the catheter (12). Yes. This lumen is for accommodating a guide wire that passes through the catheter (12) when the catheter (12) is guided into the pulmonary vein (14). This lumen can also be used to introduce contrast media into the pulmonary vein (14) at a location distal from the balloon (20, 22) of the catheter (12) during the ablation procedure. . The second lumen of the catheter (12) extends from the front end (16) of the catheter to one or more electrodes (30) located near the distal end (18) of the catheter (12). An electrode conductive wire is accommodated. The third lumen is for introducing a conductive medium into the inner second balloon (22). This medium is used to inflate the inner second balloon (22). For introduction of the medium at this position, a hole (24) is formed in the catheter (12) at a position inside the inner second balloon (22) as shown in FIGS. The fourth lumen is for introducing a conductive medium, preferably a saline solution, into the interior of the outer first balloon (20). In order to receive this conductive binder, as shown in FIGS. 6 and 7, it is preferably located at both the front side and the far side of the inner second balloon (22) and inside the first balloon (20). Thus, the catheter (12) is provided with a medium introduction hole (26). This conductive medium transmits the energy from the electrode (30) attached to the catheter (12) to the inner surface of the pulmonary vein (14) via the balloon hole (28) provided in the surface (34) of the outer balloon (22). It is for telling to touch. The catheter (12) may have additional lumens for other conventional uses.
[0040]
The present invention also provides an introduction system for introducing a conductive medium into the interior space of the outer first balloon (20) and the interior of the first balloon (20), but the second balloon (22). Also included is an ablation system attached to the outer surface (13) of the catheter (12) at an outer location. To aid in the formation of circumferential ablation wounds, for example, a sensor (not shown) for sensing the presence of extraatrial contraction, a temperature sensor (not shown) for sensing the temperature of the tissue to be ablated, the lung Includes markers (not shown) for marking the position of the catheter (12) and its parts within the vein (14), and other conventional parts commonly used for ablation catheters (12) Other parts may be attached to the catheter (12).
[0041]
The two balloons (20, 22) are attached to the outer surface (13) of the catheter (12) as shown in FIGS. The size of the outer first balloon (20) is typically about 10 mm (0.4 in) to about 100 mm (4.0 in) long and open as shown in FIGS. Sometimes it is generally oval. The maximum diameter of the outer first balloon (20) when fully inflated can vary up to about 60 mm (2.4 in). The inner second balloon (22) is also attached to the outer surface (13) of the catheter (12), and the attachment (attachment) position is as shown in FIGS. 5, 6 and 7 of the outer first balloon (20). Inside. When inflated, the size of the inner second balloon (22) is about 2 mm (0.1 in) to about 100 mm (4.0 in) in length, preferably about 5 mm (0.2 in) to about 20 mm (0.8 in). ) And the diameter is approximately the same as the outer first balloon (20). As shown in FIGS. 5, 6 and 7, the inflation of the inner second balloon (22) also caused the inflation of the outer first balloon (20), causing the outer balloon (20) to inflate throughout the ablation procedure. It is preferable to maintain the state.
[0042]
Balloons (20, 22) are manufactured according to conventional techniques from materials such as soft or thermoplastic rubber, urethane, latex, cellulose or other conventional materials and are routinely attached to catheter (12).
[0043]
Inflation of the balloon (20, 22) is carried out in a conventional manner, preferably using a radiopaque contrast solution, more preferably a marked saline solution. If desired, a radiopaque marker band (not shown) may be attached to the surface (34) of the outer first balloon (20) to mark its relative position within the pulmonary vein (14). May be. Once the proper position in the pulmonary vein (14) or at the pulmonary vein mouth is determined, the catheter (12) is pulled back slightly from that position and the subsequent circumferential ablation wound is the source of extra-atrial contraction It may be located on the nearer side.
[0044]
The balloons (20, 22) should completely block the flow of blood through the pulmonary veins (14) around these balloons (20, 22) when properly inflated. The balloon (20, 22) is preferably inflated by introducing a medium from a hole (24) provided in the inner second balloon (22), whereby the inner balloon (22) and the outer balloon (20). Both inflates. Alternatively or in addition, another medium may be introduced from the medium introduction hole (26) provided in the catheter (12) inside the outer balloon (20) to aid in its expansion. To ensure that the balloon (20, 22) forms a tight seal within the pulmonary vein (14), the distal tip opening (32) provided at the distal tip (18) of the catheter (12) A contrast medium may be injected. If a leak is found, additional media can be introduced into the inner balloon (22) until the balloon (20, 22) completely stops the blood flow in the pulmonary vein (14). .
[0045]
When the balloons (20, 22) are properly inflated, the medium introduction hole (26) provided on the outer surface (13) of the catheter (12) at the front side (front side) and the far side of the inner second balloon (22). ) To introduce the conductive medium into the outer balloon (20). As shown in FIGS. 6 and 7, it is preferable to provide two such medium introduction holes (26) in the catheter (12) both at the front side and the far side from the inner second balloon (22). In one embodiment, the conductive medium is a saline solution marked with a marker so that it can be monitored by fluoroscopy, but any suitable conductive medium can be used.
[0046]
A balloon hole (28) is provided in the surface (34) of the outer first balloon (20), for example, as shown in FIGS. In one preferred embodiment, these balloon holes (28) are formed in a series of straight lines that circle around the surface (34) of the outer first balloon (20). These balloon holes (28) may be formed in a single line, but in a preferred embodiment, as shown in FIGS. 6 and 7, these balloon holes are respectively formed on the outer first balloon (20). ) Form two or more lines that run around the surface (34) completely.
[0047]
In another embodiment, these linear balloon holes (28) are located farther from the inner second balloon (22) in the outer first balloon (20), as shown in FIG. Only provided. This alternative structure allows the conductive medium to focus on the tissue surface in the pulmonary vein (14), farther than the inner balloon (22), without dissipating into the left atrium (11). Can do.
[0048]
The electrode (30) disposed inside the outer first balloon (20) but outside the inner second balloon (22) preferably generates high frequency energy. This high frequency energy is transmitted to the tissue inside the pulmonary vein (14) from the balloon hole (28) provided in the surface (34) of the outer first balloon (20) by the conductive medium. Since these balloon holes (28) are formed in one or more lines around the surface (34) of the outer first balloon (20), the conductive energy generated by the electrode (30) is A circumferential wound is formed inside the pulmonary vein (14).
[0049]
The preferred source of ablation energy is radio frequency energy, although other energy sources such as microwaves, ultrasound or heat can be utilized. During the ablation procedure, energy from the catheter (12) is transferred to tissue inside the pulmonary vein (14) by a conductive medium. In one preferred embodiment, the impedance of the conductive medium should be less than the impedance of human tissue so that the tissue heats up to the ablation temperature at a faster rate than the conductive medium.
[0050]
The ablation system can consist of a pair of coil electrodes (30) as shown in FIGS. 6 and 7, or a pair of ring electrodes (130) as shown in FIGS. In one preferred embodiment, the two electrodes are either a coil (30) or a ring (130), one on the front (front) side of the inner balloon (22) and the other on the far side, both on the outer balloon ( At the position inside 20), it is attached to the catheter (12).
[0051]
To monitor the formation of the ablation wound, a temperature sensor (not shown) such as a thermistor or thermocouple may be attached to the outer surface (13) of the catheter (12). Sensing electrodes (not shown) can be attached to the
[0052]
In operation, a modified Seldinger method is usually employed to insert the medical device (10) into the body. When using this method, a small skin incision is made at an appropriate location to facilitate passage through the catheter or dilator. Next, after incising the subcutaneous tissue, the blood vessel is punctured with an appropriate needle with a stylet positioned at a relatively shallow angle. The needle is then withdrawn incompletely and reinserted into the blood vessel at a slightly different angle to ensure that the needle remains in the blood vessel. The soft, flexible tip of an appropriately sized guide wire is then inserted into the blood vessel through the needle and slightly beyond the needle. Remove the needle while holding the guidewire firmly in place and leave a portion of the guidewire exposed outside the vessel. The guide wire is then advanced to the right femoral vein and further into the right atrium via the inferior vena cava. (A preferred treatment approach is to approach the left and right atrium from below. A retrograde approach to the left atrium and an approach from above is also within the scope of the present invention.) The guidewire was then held in place. Leave the dilator along with the introducer around the guidewire. The dilator and introducer typically form an assembly that is advanced along the guide wire into the inferior vena cava. The introducer may be a conventional linear introducer, but is preferably a pre-curved introducer, such as the SL2 introducer sold by Dage Corporation.
[0053]
A Brockenbrough or trocar (trocar) is then inserted through the lumen of the dilator to the right atrium and used to form an opening through the atrial septum, preferably in the fossa . The entire device (dilator, introducer, and Brockenblow needle) is advanced from the vena cava into the right atrium with the tip hitting the atrial septum at the level of the foveal fossa. The Brockenblow needle is then advanced past the foveal fossa. After making an opening through the atrial septum, replace the Brocken blow needle with a guide wire. Advance the dilator, guidewire and lead introducer for the left atrium into the left atrium. The dilator is then removed, leaving the introducer and guidewire in place in the left atrium. The ablation catheter (12) is then advanced around the guide wire and advanced through the lumen of the introducer and into the left atrium. The guide wire is then steered so that it enters the proper pulmonary vein (14). Next, the catheter (12) through which the guide wire is passed is advanced into the pulmonary vein, and the guide wire is taken out.
[0054]
Once the distal end (16) of the ablation catheter (12) is advanced into the pulmonary vein (14), a sensing electrode (not shown) attached to or near the distal end (16) of the catheter (12) ) May be used to position the catheter. The sensing tip electrode senses electrical activity within the pulmonary vein (14), including pre-atrial contraction. After confirming that the source of the atrial premature contraction is farther from the inner balloon (22) and the outer balloon (20), the medium is introduced from the medium introduction hole (26) of the catheter (12) to introduce the inner balloon (22). Inflate. When the inner balloon (22) is inflated, the outer balloon (20) is also inflated. The inner balloon (22) and outer balloon (20) must be inflated sufficiently to completely block blood flow through the pulmonary veins (14) around these balloons (20, 22). In order to ensure that no blood flows around the balloon (20, 22), the marked medium is moved further away from the balloon (20, 22), e.g. on the far side of the catheter (12). It may be injected into the pulmonary vein (14) from the tip opening (32) provided at the tip (18). Thereafter, the presence or absence of leakage around the balloon (20, 22) is determined by fluoroscopy, and if there is leakage, additional pressure can be applied to the inside of the inner balloon (22) to eliminate the leakage. it can.
[0055]
Thereafter, an ablation system, preferably a pair of high frequency coil electrodes (30) or rings mounted on the outer surface (13) of the catheter (12) at a location outside the inner balloon (22) inside the outer balloon (20). The electrode (130) generates energy, which is transmitted by the conductive medium to the tissue surface of the pulmonary vein (14) via the balloon hole (28) of the surface (34) of the outer balloon (20). . Sufficient energy is generated to create a circumferential wound of sufficient width and depth to completely block the transmission of extra-atrial contraction through the pulmonary vein (14). A temperature sensor (not shown) such as a thermistor or a thermocouple mounted on the surface 13) of the
[0056]
After the ablation procedure is completed and tested with sensing electrodes, each element of the system is removed from the pulmonary vein (14) and left atrium (11). If desired, another sensing instrument can be introduced into the left atrium (11) to determine if there are other sources of extra-atrial contractions in other pulmonary veins (14).
[0057]
While specific forms of the invention have been illustrated and described above, it will be apparent from the foregoing that various modifications can be made without departing from the spirit and scope of the invention. For example, the present invention can also be used for ablation procedures in other blood vessels or vessels such as the coronary sinus and other veins.
[Brief description of the drawings]
FIG. 1 is a cutaway view of the heart showing the left atrium and four pulmonary veins.
FIG. 2 is a cutaway view of the left atrium showing the ablation catheter of the present invention introduced into one of the pulmonary veins.
FIG. 2A is a cutaway view of an ablation catheter of the present invention introduced into one of the pulmonary veins.
FIG. 3 is a perspective view of an ablation catheter of the present invention in which the balloon is not inflated.
4 is a perspective view of the distal portion of the ablation catheter of FIG. 3 with no balloon inflated.
5 is a cutaway perspective view of the ablation catheter of FIG. 3 with a balloon inflated.
6 is a cutaway perspective view of the distal portion of the ablation catheter of FIG. 5 with the balloon inflated.
7 is a cutaway side view of the distal portion of the ablation catheter of FIG. 5 with the balloon inflated.
FIG. 8 is a cutaway side view of the distal portion of the ablation catheter with the balloon inflated showing another aspect of the location of the balloon hole of the outer first balloon.
9 is a cutaway perspective view of another embodiment of the ablation catheter of FIG. 7 in which a ring electrode is provided in place of the coil electrode.
10 is a cutaway side view of a distal portion of another embodiment of the ablation catheter of FIG. 9. FIG.
Claims (17)
アブレーションカテーテル、
血管をシールしてその血管を通る血液の流れを実質的に阻止するための、カテーテルに取り付けられ、導電性媒体を通すバルーン穴を備えた外側の第1バルーン、
外側の第1バルーンの内部の位置でカテーテルに取り付けられた、膨張可能で、膨張して外側の第 1 バルーンを膨らませることができる内側の第2バルーン、
外側の第1バルーンの内部であって、かつ内側の第2バルーンの外部に導電性媒体を導入するための、カテーテルに取り付けられた導入システム、および
外側の第1バルーン内であって内側の第2バルーンの外部の位置でカテーテルに取り付けられた1または2以上のアブレーション電極を備えたアブレーション要素。A medical device for the treatment of arrhythmias by ablation within the blood vessels associated with the human heart, comprising:
Ablation catheter,
An outer first balloon with a balloon hole attached to the catheter and through which a conductive medium passes to seal the blood vessel and substantially prevent blood flow through the blood vessel;
An inner second balloon that is inflatable and can be inflated to inflate the outer first balloon , attached to the catheter at a location inside the outer first balloon;
An internal of the outer first balloon, and external for introducing a conductive media into the inside of the second balloon, the inner be in the first balloon introduction system, and the outer attached to catheter 2. An ablation element with one or more ablation electrodes attached to the catheter at a location outside the balloon .
前方端部と遠方端部とを有し、その前方端部から遠方端部まで内部を貫通する内腔を持った導入器、
導入器の内腔の内部に挿入されたアブレーションカテーテル、
血管をシールしてその血管を通る血液の流れを実質的に阻止するための、カテーテルに取り付けられ、導電性媒体を通すバルーン穴を備えた外側の第1バルーン、
外側の第1バルーンの内部の位置でカテーテルに取り付けられた、膨張可能で、膨張して外側の第 1 バルーンを膨らませることができる内側の第2バルーン、
外側の第1バルーンの内部であって、かつ内側の第2バルーンの外部に導電性媒体を導入するための、カテーテルに取り付けられた導入システム、および
外側の第1バルーン内であって内側の第2バルーンの外部の位置でカテーテルに取り付けられた1または2以上のアブレーション電極を備えたアブレーション要素。A medical device for the treatment of arrhythmias by ablation within the blood vessels associated with the human heart, comprising:
An introducer having a front end portion and a far end portion and having a lumen penetrating the inside from the front end portion to the far end portion;
An ablation catheter inserted inside the lumen of the introducer,
An outer first balloon with a balloon hole attached to the catheter and through which a conductive medium passes to seal the blood vessel and substantially prevent blood flow through the blood vessel;
An inner second balloon that is inflatable and can be inflated to inflate the outer first balloon , attached to the catheter at a location inside the outer first balloon;
An introduction system attached to the catheter for introducing a conductive medium within the outer first balloon and outside the inner second balloon, and within the outer first balloon, the inner first balloon ; 2. An ablation element with one or more ablation electrodes attached to the catheter at a location outside the balloon .
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US09/233,337 | 1999-01-20 | ||
US09/233,337 US6251109B1 (en) | 1997-06-27 | 1999-01-20 | Process and device for the treatment of atrial arrhythmia |
PCT/US2000/000315 WO2000042934A1 (en) | 1999-01-20 | 2000-01-07 | Device for the treatment of atrial arrhythmia |
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JP2002535033A JP2002535033A (en) | 2002-10-22 |
JP4240819B2 true JP4240819B2 (en) | 2009-03-18 |
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Application Number | Title | Priority Date | Filing Date |
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JP2000594396A Expired - Lifetime JP4240819B2 (en) | 1999-01-20 | 2000-01-07 | Atrial arrhythmia treatment device |
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US (4) | US6251109B1 (en) |
EP (1) | EP1063935B1 (en) |
JP (1) | JP4240819B2 (en) |
AT (1) | ATE291381T1 (en) |
CA (1) | CA2324461A1 (en) |
DE (1) | DE60018850T2 (en) |
WO (1) | WO2000042934A1 (en) |
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ATE291381T1 (en) | 2005-04-15 |
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